A Phase 3 interventional study of 5mg Serlopitant Tablets and Placebo Tablets in Pruritus and Prurigo Nodularis, sponsored by Vyne Therapeutics Inc.. Completed at 40 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Vyne Therapeutics Inc. · Phase 3, Interventional, and Treatment
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Among 58 studies in Pruritus with a site in Germany — 5 open to participants now, 8 under way, 4 of them phase 3. Pruritus · Germany.
Among the 58 studies in Pruritus with a site in Germany, this one is the 16th largest by enrollment of the 56 interventional ones that give a count, is one of 13 that started in 2018, is one of 22 in phase 3, and was the 33rd registered.
491 studies on the registry are indexed under Pruritus; 94 are open to participants now.
Browse Pruritus studies →5 of the 58 studies in Pruritus with a site in Germany are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Germany, United States, Argentina and 13 more countries
Ages 12–17
Pfizer · Sites in Germany, United States, Bulgaria and 7 more countries
Ages 18+
Mirum Pharmaceuticals, Inc. · Sites in Germany, Belgium, France and 5 more countries
Ages 2 mo+
Sanofi · Sites in Germany, United States, Argentina and 10 more countries
Ages 18–90
AB Science · Sites in Germany, France, Netherlands and 5 more countries
Ages 18–75
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 24 · Phase 3 25 · Phase 4 4
First in 2005; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 295 is above the median of 60 across 423 interventional studies indexed under Pruritus.
Median enrollment 153 across the 56 interventional studies, 1,580 across the 2 observational. Of the 50 that completed or were terminated, 31 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
53 of 58 have an industry lead sponsor. The 10 most frequent:
This study is registered under Vyne Therapeutics Inc., one of the names counted as Yarrow Bioscience, Inc.. Under that name alone:
Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Yarrow Bioscience, Inc. has 8 studies filed under Pruritus — fewer than ten, so there is no comparison to draw.
3 of the studies in Pruritus with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05263206Phase 3SanofiEfficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) | 2027-06-02 |
| NCT07219615PfizerA Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. | 2026-12-25 |
| NCT05050136Mirum Pharmaceuticals, Inc.A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | 2027-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 58 studies in Pruritus with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
Inclusion Criteria (Subjects must meet the following criteria to be randomized into the study:
Exclusion Criteria (Subjects who meet any of the following criteria are not eligible for participation in the study):
Treatment with any of the following therapies within 4 weeks.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 5mg Serlopitant Tablets
Drug: Placebo Tablets
Serlopitant Tablets
Also known as: VPD-737
Placebo Tablets
Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Time frame: At Week 10
Percent of Participants With WI-NRS 4-point Responder Rate at Week 4
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Time frame: At Week 4
Percent of Participants With WI-NRS 4-point Responder Rate at Week 2
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Time frame: At Week 2
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
Time frame: At Weeks 2, 4, 6, and 10
Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3).
Time frame: At Weeks 2, 4, and 10
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a participant's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.).
Time frame: At Week 10
Change From Baseline in DLQI Question 1 to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a participant's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.).
Time frame: At Week 10
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10
The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Time frame: At Weeks 2, 4 and 10
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Time frame: At Weeks 2, 4, and 10
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
Time frame: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for participants who discontinued study drug early
The study was conducted at 40 sites in US from 29 August 2018 to 06 February 2020. All psrticipants who met the study entry criteria were randomized in a 1:1 ratio to receive daily oral doses of serlopitant 5 mg or placebo.
| Milestone | Placebo | Serlopitant 5 mg |
|---|---|---|
| Started | 148 | 147 |
| Completed | 138 | 129 |
| Not completed | 10 | 18 |
| Withdrew: Adverse event | 4 | 14 |
| Withdrew: Lack of efficacy | 3 | 1 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Sponsor decision | 0 | 1 |
| Withdrew: Reason unspecified | 1 | 0 |
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
| Percentage of participants | Placebo | Serlopitant 5 mg |
|---|---|---|
| Success | 18.95 | 25.90 |
| Failure | 81.05 | 74.10 |
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
| percentage of participants | Placebo | Serlopitant 5 mg |
|---|---|---|
| Success | 11.49 | 12.63 |
| Failure | 88.51 | 87.37 |
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
| percentage of participants | Placebo | Serlopitant 5 mg |
|---|---|---|
| Success | 6.76 | 5.55 |
| Failure | 93.24 | 94.45 |
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
| Score on a scale | Placebo | Serlopitant 5 mg |
|---|---|---|
| Change from Baseline at Week 2 | -0.94 ± 1.470 | -1.25 ± 1.496 |
| Change from Baseline at Week 4 | -1.42 ± 1.908 | -1.60 ± 1.955 |
| Change from Baseline at Week 6 | -1.61 ± 2.105 | -1.93 ± 2.182 |
| Change from Baseline at Week 10 | -1.86 ± 2.334 | -2.24 ± 2.543 |
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3).
| Percentage of participants | Placebo | Serlopitant 5 mg |
|---|---|---|
| Percentage of responders at Week 2 | 8.11 | 11.89 |
| Percentage of responders at Week 4 | 18.24 | 20.03 |
| Percentage of responders at Week 10 | 25.65 | 37.58 |
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a participant's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.).
| Score on a scale | Placebo | Serlopitant 5 mg |
|---|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | -4.4 ± 5.07 | -4.5 ± 5.14 |
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a participant's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.).
| Score on a scale | Placebo | Serlopitant 5 mg |
|---|---|---|
| Change From Baseline in DLQI Question 1 to Week 10 | -0.6 ± 0.75 | -0.6 ± 0.76 |
The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
| Score on a scale | Placebo | Serlopitant 5 mg |
|---|---|---|
| Change from Baseline at Week 2 | -0.2 ± 0.43 | -0.2 ± 0.43 |
| Change from Baseline at Week 4 | -0.4 ± 0.64 | -0.3 ± 0.64 |
| Change from Baseline at Week 10 | -0.5 ± 0.77 | -0.5 ± 0.78 |
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
| Score on a scale | Placebo | Serlopitant 5 mg |
|---|---|---|
| Change from Baseline at Week 2 | -0.2 ± 0.49 | -0.3 ± 0.49 |
| Change from Baseline at Week 4 | -0.5 ± 0.68 | -0.5 ± 0.68 |
| Change from Baseline at Week 10 | -0.7 ± 0.91 | -0.7 ± 0.92 |
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
| Participants | Placebo | Serlopitant 5 mg |
|---|---|---|
| Participants with any TEAE | 87 | 84 |
| Participants with any related TEAE | 24 | 30 |
| Participants with any serious TEAE | 2 | 5 |
| Participants with any related serious TEAE | 0 | 0 |
| Participants who Died | 0 | 0 |
| Participants who discontinued study drug | 4 | 13 |
Collected over From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for participants who discontinued study drug early.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/148 (0%) | 2/148 (1.4%) | 33/148 (22.3%) |
| Serlopitant 5 mg | 1/147 (0.7%) | 5/147 (3.4%) | 31/147 (21.1%) |
| Event | Placebo | Serlopitant 5 mg |
|---|---|---|
| Coronary artery diseaseCardiac disorders | 0/148 | 1/147 |
| WoundInjury, poisoning and procedural complications | 0/148 | 1/147 |
| Hepatic enzyme increasedInvestigations | 0/148 | 1/147 |
| Crystal arthropathyMusculoskeletal and connective tissue disorders | 0/148 | 1/147 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/148 | 1/147 |
| B-cell lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/148 | 1/147 |
| Type 2 diabetes mellitusMetabolism and nutrition disorders | 1/148 | 0/147 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 1/148 | 0/147 |
| Hypertensive crisisVascular disorders | 1/148 | 0/147 |
| Event | Placebo | Serlopitant 5 mg |
|---|---|---|
| NasopharyngitisInfections and infestations | 22/148 | 15/147 |
| HeadacheNervous system disorders | 5/148 | 9/147 |
| FatigueGeneral disorders | 6/148 | 7/147 |
| Age, Continuous(years) | Placebo | Serlopitant 5 mg | Total |
|---|---|---|---|
| Mean | 58.5 ± 12.97 | 57.5 ± 15.33 | 58.0 ± 14.18 |
| Sex: Female, Male(Participants) | Placebo | Serlopitant 5 mg | Total |
|---|---|---|---|
| Female | 94 | 98 | 192 |
| Male | 54 | 49 | 103 |
| Race (NIH/OMB)(Participants) | Placebo | Serlopitant 5 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 145 | 145 | 290 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2018 to primary completion in Jan 2020, 16 months.
Results were first posted in Oct 2020, 9 months after primary completion.
Of 42 industry-sponsored phase 3 interventional studies under Pruritus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 26. This study's 16 months is below that.
Counting every sponsor, half of 48 studies reached it within 19 months; a quarter within 12 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Serlopitant